Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis Pilot Study

Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis Pilot Study - Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030743

Enrollment

Registered

2018-01-15

Start date

2019-03-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Hepatitis

Interventions

Tacrolimus

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who had diagnosis of Autoimmune Hepatitis by guideline of 2013 2) Patients is poorly tolerated by Predniso(lo)ne, alone or in combination with azathioprine 3 Patients who can not treated with azathioprine due to adverse event

Exclusion criteria

Exclusion criteria: 1. Liver cirrhosis 2. HBV , HCV, PBC, NASH 3. Arrergy of Tacrolimus 4. Arrergy of ciclosporin 5. Patents who treated with potassium-conserving diuretic 6. Pregnancy 7. Patients who hope of pregnancy 8. Severe infection 9. Patients who judge exclusion criteria by doctor

Design outcomes

Primary

Measure	Time frame
The rate of patients who had normal ALT at 2 weeks from initial tacrolimus treatment The duration which had normal ALT at 2 weeks from initial tacrolimus treatment The rate of patients who had normal IgG at 2 weeks from initial tacrolimus treatment The duration which had normal IgG at 2 weeks from initial tacrolimus treatment The rate of patients who had normal ALT at 2 years from initial tacrolimus treatment The rate of patients who had normal IgG at 2 years from initial tacrolimus treatment Safety	—

Measure

Time frame

The rate of patients who had normal ALT at 2 weeks from initial tacrolimus treatment The duration which had normal ALT at 2 weeks from initial tacrolimus treatment The rate of patients who had normal IgG at 2 weeks from initial tacrolimus treatment The duration which had normal IgG at 2 weeks from initial tacrolimus treatment The rate of patients who had normal ALT at 2 years from initial tacrolimus treatment The rate of patients who had normal IgG at 2 years from initial tacrolimus treatment Safety

—

Countries

Japan

Contacts

Public ContactTomokazu Kawaoka

Hiroshima University Hospital Department of Gastroenterology and Metabolism

kawaokatomo@hiroshima-u.ac.jp082-257-5555

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026